A trial looking at chemotherapy after surgery for small bowel cancer (BALLAD)

Cancer type:

Small bowel cancer

Status:

Open

Phase:

Phase 2

This trial is comparing different types of chemotherapy with no chemotherapy after surgery for small bowel cancer. The trial is supported by Cancer Research UK.

More about this trial

If your cancer hasn’t spread to another part of your body, doctors usually treat small bowel cancer with surgery first. Doctors aren’t sure if it is best to give chemotherapy after surgery to reduce the risk of the cancer coming back or not. So they want to find out more. Chemotherapy has side effects and it is important that patients don’t have treatments they don’t need.

In this trial, researchers are looking at 3 different chemotherapy drugs called fluorouracil (also known as 5FU), capecitabine and oxaliplatin after surgery. There are 2 different parts to this trial. So depending on which part you join,

  • Some people don’t have chemotherapy
  • Some people have 5FU or capecitabine
  • Some people have 5FU or capecitabine alongside oxaliplatin

The aims of the trial are to

  • Find out if having chemotherapy after surgery reduces the risk of the cancer coming back
  • Find out if adding oxaliplatin to chemotherapy is a useful treatment after surgery
  • Learn more about the side effects

Who can enter

You may be able to join this trial if all of the following apply. You

  • Have a type of small bowel cancer called adenocarcinoma that has grown into surrounding tissues and may have spread to nearby lymph nodes Open a glossary item but hasn’t spread to another part of your body (stage 1, 2 or 3 small bowel cancer)
  • Have had an operation to remove your cancer
  • Can start chemotherapy with 14 weeks of having your operation
  • Are well enough to carry out all your normal activities, apart from heavy physical work (performance status 0 or 1)
  • Have satisfactory blood test results
  • Are at least 16 years old
  • Are willing to use reliable contraception during the trial if there is any chance you or your partner could become pregnant.

You cannot join this trial if any of these apply.

  • Your tissue sample (biopsy Open a glossary item) shows that you have any cancer cell other than adenocarcinoma
  • You had chemotherapy Open a glossary item or radiotherapy Open a glossary item before surgery
  • You have a condition called dihydropyrimidine dehydrogenase deficiency (the trial team can tell you more about this)
  • You have coeliac disease Open a glossary item that isn’t well controlled
  • You have inflammation of the bowel that you have had for a long time
  • You have a blocked bowel or problems absorbing tablets
  • You have moderate to severe tingling or numbness in your hands or feet (peripheral neuropathy)
  • You are known to be sensitive to platinum salts (the trial team can tell you more about this)
  • You have an active infection or any other medical condition that means you can’t have chemotherapy
  • You have certain heart problems (the trial team can tell you more about this)
  • You don’t have enough of a vitamin in your body called B12
  • You have significant hearing loss so can’t have oxaliplatin. You still may be able to take if your doctor thinks you are suitable to have fluorouracil or capecitabine instead. You doctor can tell you more about this.
  • You have had experimental treatment as part of a clinical trial in the last month
  • You have had another cancer in the last 3 years apart from successfully treated early cancers Open a glossary item or any other cancer that has been treated with the aim to cure and there hasn’t been any sign of it for at least 3 years
  • You are pregnant or breast feeding

Trial design

This phase 2 trial aims to recruit more than 500 people worldwide. Everyone taking part will have had surgery to remove their small bowel cancer.

At the beginning of the trial, your doctor will talk to you about whether or not you are likely to benefit from having chemotherapy. If you and your doctor agree that it is uncertain whether you will benefit from chemotherapy, you join part 1.

If they think you are likely to benefit, you join part 2 and definitely have chemotherapy.

For both part 1 and 2, you and your doctors decide before randomisation which type of chemotherapy is best for you. The 2 treatment options are capecitabine or fluorouracil.

Part 1 of the trial is randomised. You are put into 1 of 3 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

  • One group have no chemotherapy
  • One group have 5FU or capecitabine
  • One group have 5FU or capecitabine with oxaliplatin

Part 2 of the trial is for people likely to benefit from chemotherapy. You are put into one of the following groups at random.

  • One group have 5FU or capecitabine and oxaliplatin
  • The other group have 5FU or capecitabine

Some people may have thought about taking part in the trial but decided not to. The trial team may ask this group of people for a blood sample and to test a sample of tissue taken from when you had surgery.

If you are having 5FU, you have it as a continuous infusion via a small pump over 2 days every 2 weeks.

If you have capecitabine, you take this as tablets twice every day for 2 weeks. Then a week with no treatment.

If you have oxaliplatin, you have it through a drip into a vein once every 3 weeks. It takes about 2 hours each time.

Everyone has treatment for up to 6 months.

You have extra blood tests as part of this trial. Where possible you have these at the same time as your routine blood tests. The researchers want to look for substances called biomarkers Open a glossary item to find out why treatment might work for some people and not for others.

The researchers may also ask to look at a tissue sample (biopsies) Open a glossary item that was taken when you had surgery. They will look for biomarkers and they may use it for other tests in the future. If you don’t want to give these samples for research, you don’t have to. You can still take part in the trial.

Everybody taking part will be asked to fill out a questionnaire before starting treatment, at set times during the trial and after finishing treatment. The questionnaire will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.

Hospital visits

You see the doctor to have some tests before taking part in this trial. These tests include

  • Physical examination
  • Heart trace (ECG Open a glossary item)
  • Blood tests
  • CT scan

If you have chemotherapy, you see the trial team for a check up 3 months after you finish chemotherapy and then 3 months after that.

If you didn’t have chemotherapy, you see the trial team for a check up 3 months after joining the trial and 6 months after that.

After that everyone sees the trial team

  • Every 6 months in the 2nd and 3rd year of the trial
  • Every year after that for 7 years

Everyone has a CT scan every year for 3 years after joining the trial unless your cancer gets worse.

Side effects

The most common side effects of 5FU include

The side effects of capecitabine are similar to 5FU. As well as the above, another common side effect of capecitabine includes sore hands and feet (hand-foot syndrome).

The most common side effects of oxaliplatin include

  • Numbness and tingling in your hands and feet and around your mouth
  • Being more sensitive to the cold
  • Tightness in the muscles around your throat when having the drug or just afterwards
  • Diarrhoea
  • Feeling or being sick
  • Tiredness

Location

Basingstoke
Belfast
Cardiff
Cottingham
Glasgow
Leeds
Leicester
London
Maidstone
Manchester
Nottingham
Peterborough
Portsmouth
Salisbury
Sheffield
Southampton
Sutton
Truro
Whitehaven
Winchester

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Jeff Evans
Professor Richard Wilson

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
International Rare Cancers Initiative (IRCI)
NHS Greater Glasgow and Clyde
The University of Glasgow

Other information

This is Cancer Research UK trial number CRUK/12/04.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10555

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

Rate this page:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think